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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03264365
Date of registration:	22/08/2017
Prospective Registration:	No
Primary sponsor:	Holbaek Sygehus
Public title:	The Effectiveness of a Post-ICU Recovery Program on Relatives RAPIT-II
Scientific title:	The Effectiveness of a Post-ICU Recovery Program on Relatives to Patients Receiving Mechanically Ventilatory Support: Data Linked to RAPIT-I Investigation
Date of first enrolment:	December 15, 2012
Target sample size:	181
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03264365
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Denmark

Contacts

Name:	RAPIT Steering Committee
Address:
Telephone:
Email:
Affiliation:	Region of Copenhagen Capital and Region of Zealand

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 years of age or older

- Defined by the patients

Exclusion Criteria:

- If the patients dropped out or died during the study period

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Intensive Care Unit Syndrome

Relatives

Intervention(s)

Behavioral: Intervention

Primary Outcome(s)

Mental Component Score [Time Frame: 12 months after ICU]

Secondary Outcome(s)

Anxiety [Time Frame: 12 months after ICU]

Depression [Time Frame: 12 months after ICU]

Mental Component Score [Time Frame: 3 months after ICU]

Sense of coherence [Time Frame: 3 months after ICU]

Anxiety [Time Frame: 3 months after ICU]

Physical Component Score [Time Frame: 12 months after ICU]

Depression [Time Frame: 3 months after ICU]

Physical Component Score [Time Frame: 3 months after ICU]

Post-traumatic stress Disorders [Time Frame: 3 months after ICU]

Sense of coherence [Time Frame: 12 months after ICU]

Post-traumatic stress Disorders [Time Frame: 12 months after ICU]

Secondary ID(s)

NCT-01721239

01863 HIH-2012-011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nordsjaellands Hospital

Horsens Hospital

Herlev Hospital

Rigshospitalet, Denmark

Sonderborg Hospital

Svendborg Hospital

Sydvestjysk Hospital

Naestved Hospital

Aabenraa Hospital

Nykøbing Falster County Hospital

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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